FDA 510(k) Application Details - K040793

Device Classification Name Latex Patient Examination Glove

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510(K) Number K040793
Device Name Latex Patient Examination Glove
Applicant HL RUBBER PRODUCTS SDN BHD
6324 MEETINGHOUSE WAY
ALEXANDRIA, VA 22312-1718 US
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Contact KOK-KEE HON
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 03/29/2004
Decision Date 04/14/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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